Trial of Transcranial Direct Current Stimulation (tDCS) for Depression

Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) for Depression.

Among antidepressant treatments, ECT stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). However, not all patients may respond to this treatment in the way that it is currently administered and this has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether tDCS stimulation using an alternative electrode montage has antidepressant effects.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Device: tDCS (Eldith DC-Stimulator (CE certified))

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, Sydney, New South Wales, Australia, 2031
      • Black Dog Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject meets criteria for a DSM-IV Major Depressive Episode.
2. Total MADRS score ≥20.
3. Subject has not responded to tDCS given with a standard montage OR subject is unable to receive tDCS with standard montage - for example, due to skin rash etc at site of electrode placement for standard montage.

Exclusion Criteria:

1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
3. Inadequate response to ECT in the current episode of depression.
4. Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Female subject who is pregnant.
9. Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; b) As this is a novel treatment, the study involves detailed neuropsychological testing for safety reasons. This testing cannot be effectively or validly completed by someone who is not fluent in English. Note that translation of the proposed tests into English has not been validated and that we cannot be confident that neuropsychological impairment would be detected using this method.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active tDCS	Device: tDCS (Eldith DC-Stimulator (CE certified)); Each tDCS session lasting continuously for 20 minutes at 2 mA; Other Names: Eldith DC-Stimulator (CE certified)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS).	Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment	6 months

Collaborators and Investigators

• Sponsor: The University of New South Wales

Publications and helpful links

Helpful Links

• Black Dog Institute website

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 17, 2010
• First Posted (ESTIMATE): December 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2015
• Last Update Submitted That Met QC Criteria: September 15, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: depression; direct current stimulation; alternative electrode montage
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 10368